PURPOSE Lead the end to end implementation of a Serialization Level 5 system to support US DSCSA reporting, ensuring full compliance with Computerized system Validation ( CSV) requirements per GAMP 5 / 21 CFR Part 11 / EU Annex 11. The role bridges Digital Technology (DT), Operations, Quality and external vendors to deliver a validated, production ready system on time and within budget. Key responsibilities Execution Lead: Define and maintain DT project execution plan, milestones, budget and RAID log for the L5 serialization deployment for US DSCSA regulation. Coordinate cross-functional teams: SAP Basis, UAM, SAP ATTP functional teams, Computerized System QA, IT Validation. Ensure seamless data flow between L4 (SAP ATTP) and L5 Serialization Network layer. Computerized System Validation: Lead validation lifecycle documentation in close collaboration with Functional System Owner and IT Validation expert ( URS, FRS, DS, IQ, OQ, PQ..) Ensure all validation activities comply with GAM...